HYDERABAD: Domestic pharma major Lupin has begun a voluntary recall of its contraceptive tablets Mibelas 24 Fe from the US as they are "out of sequence."
According to a notification issued by the US Food and Drug Administration (USFDA), as many as 24,652 tablets are being recalled under 'class-I' classification.
The Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) pills are oral contraceptives. These pills are packaged in blister packs containing 28 tablets.
"Contraceptive tablets out of sequence- first 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package," the FDA notification said as the reason for the recall.
According to the FDA, class-I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
The product is manufactured by Lupin and distributed by its American subsidiary Lupin Pharmaceuticals Inc.